DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000

DYNNAIL, 12MM, LOCKING SCREW, 4.6 MM, DEPLOYMENT FRAME, DYNNAIL, MODELS 1200-01-1222, 1200-02-46XX, 2200-01-0000 is an FDA 510(k)-cleared medical device (K101934) manufactured by Medshape Solutions. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 2, 2011. Regulation: 8.